In Thorn v. Medtronic Sofamor Danek, USA, the Honorable Janet T. Neff dismissed the plaintiff's state law claims of failure to warn and negligence as preempted under the Medical Device Amendments of 1976 ("MDA"), 28 U.S.C. §...more

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

Today’s case, blogger fanatics, is a good illustration of grinding out a victory. It’s the story of a defendant calmly and effectively pressing its legal and factual arguments, winning a partial victory before trial,...more

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Reversing the dismissal of a negligent failure to warn action, the Ninth Circuit Court of Appeals carved out a key exception to the immunity afforded to website operators under the Communications Decency Act (CDA)....more

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations...more

On January 21, 2014, the Pennsylvania Supreme Court held in a 4–2 vote in Lance v. Wyeth, 2014 PA. 17 EAP 2011 (PA Supreme Court 2014), that a pharmaceutical company for the first time under Pennsylvania law may face...more

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

On October 24, 2013, the Florida Supreme Court reinstated a $1.2 million final judgment awarded to a prospective client of a personal injury law firm who sat in a chair that collapsed during a consultation at the firm. See...more

In a decision released on August 27, 2013, Justice Belobaba of the Ontario Superior Court of Justice certified a class action against DePuy Orthopaedics Inc. on behalf of persons who were surgically implanted with any one of...more

In most states that use a “risk utility” test to determine whether a product is “not reasonably safe” (i.e. defective) as designed, an alternative design for the product is generally considered to be a critical element of the...more

As reported by the New York Times and Forbes, airbag supplier Takata Corp. announced to the National Highway Traffic Safety Administration (NHSTA) that some of its products had the possibility of malfunctioning. ...more

"Dear Doctor" letters were front and center in the recently tried case of Tietz v. Abbott Laboratories Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...more